Karolinska Institutet, SE-171 77 Stockholm, Sweden.
Hum Reprod. 2012 Mar;27(3):695-701. doi: 10.1093/humrep/der434. Epub 2012 Jan 9.
Endometriosis is a chronic inflammatory disease of unknown aetiology that can cause severe dysmenorrhea. Lignocaine has anti-inflammatory properties and exerts effects on nerve endings and intra-peritoneal macrophages. The objective of this study was to evaluate the effect of pertubation with Ringer-Lignocaine on dysmenorrhea in women with endometriosis.
A double-blind randomized controlled trial (RCT) was carried out at three sites in Stockholm, Sweden. Eligible patients had endometriosis as diagnosed by laparoscopy, dysmenorrhoic pain >VAS 50 mm (visual analogue scale) and patent Fallopian tubes. The study patients were randomized sequentially to preovulatory pertubations with placebo (n= 18) or study treatment (n= 24) during three consecutive menstrual cycles. The pertubation procedure comprised passing study solution through the uterine cavity and the Fallopian tubes via an intra-cervical balloon catheter. The effect on pain was evaluated with VAS scales before and after the treatments and up to nine menstrual cycles after the last pertubation. Success was defined as a reduction of ≥ 50% on the VAS scale after the third pertubation. The success rate between the treatment and the placebo group was compared with Fisher's exact test.
In the intention-to-treat analysis, the success rate was 41.7% (10 of 24) in the treatment group compared with 16.7% (3 of 18) in the placebo group (P= 0.10, 95% CI -7.3 to 36.2%). In the per protocol analysis, the success rate in the treatment group was 45% (9 of 20) compared with 7.1% (1 of 14) in the placebo group (P= 0.024, 95% CI -2.6 to 44.8%). Of the nine patients in the lignocaine group who fulfilled the criteria for success after three pertubations, 4 (44%) had an effect persisting after nine months. The treatments were well tolerated.
This small RCT indicates that pertubation with lignocaine is a non-hormonal treatment option for patients with dysmenorrhea and endometriosis. ClinicalTrials.gov identifier: NCT01329796.
子宫内膜异位症是一种病因不明的慢性炎症性疾病，可导致严重的痛经。利多卡因具有抗炎作用，并对神经末梢和腹腔巨噬细胞发挥作用。本研究的目的是评估 Ringer-利多卡因灌洗对子宫内膜异位症患者痛经的影响。
在瑞典斯德哥尔摩的三个地点进行了一项双盲随机对照试验（RCT）。符合条件的患者经腹腔镜诊断为子宫内膜异位症，痛经疼痛>VAS50mm（视觉模拟量表）且输卵管通畅。研究患者在三个连续的月经周期中按顺序随机分为排卵前安慰剂（n=18）或研究治疗（n=24）灌洗。灌洗程序包括通过宫颈内球囊导管将研究溶液通过子宫腔和输卵管输送。治疗前后和最后一次灌洗后 9 个月经周期内用 VAS 量表评估疼痛效果。第三次灌洗后 VAS 量表降低≥50%定义为成功。用 Fisher 确切检验比较治疗组和安慰剂组的成功率。
意向治疗分析中，治疗组的成功率为 41.7%（24 例中有 10 例），安慰剂组为 16.7%（18 例中有 3 例）（P=0.10，95%CI-7.3 至 36.2%）。在方案分析中，治疗组的成功率为 45%（20 例中有 9 例），安慰剂组为 7.1%（14 例中有 1 例）（P=0.024，95%CI-2.6 至 44.8%）。在符合三次灌洗成功标准的 9 例利多卡因组患者中，4 例（44%）的疗效持续 9 个月。治疗均耐受良好。
这项小型 RCT 表明，利多卡因灌洗是子宫内膜异位症痛经患者的一种非激素治疗选择。临床试验注册号：NCT01329796。
